MAUDE Adverse Event Report: CONVATEC, INC. FLEXI-SEAL FMS-FECAL MANAGEMENT SYSTEM KIT; GASTROINTESTINAL TUBE & ACCESSORIES

Device Problems Collapse (1099); Material Discolored (1170); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that after approximately 5 days in use, the flexi-seal fms 'does not maintain its's balloon shape, softens, collapses and changes color after an average of a week.' it was reported that patient was receiving the drug, epilim, while the device was in use.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.No further information was available at the time of the report.Additional patient/event details have been requested.There were no reports of the patient being hared as a result of this malfunction.Should additional information become available, a follow up report will be submitted.

• Brand Name: FLEXI-SEAL FMS-FECAL MANAGEMENT SYSTEM KIT
• Type of Device: GASTROINTESTINAL TUBE & ACCESSORIES
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4956064
• MDR Text Key: 6195288
• Report Number: 1049092-2015-00445
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K032734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 53 YR